Why it was recalled
Cross contamination: the excipient was found to be contaminated with theophylline.
Product description
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
Lot numbers, UPCs & expiration codes
Batch # 18472036, 18472041.
Where it was sold
USA Nationwide and Worldwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0149-2021
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Nov 17, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 4560 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BASF Corporation
Original FDA data
Every field from FDA enforcement report D-0149-2021, exactly as published.
Show all FDA fields
- City
- Florham Park
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 86805
- Address
- 100 Park Ave
- Code information
- Batch # 18472036, 18472041.
- Postal code
- 07932-1049
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0149-2021
- Classification
- Class II
- Recalling firm
- BASF Corporation
- Product quantity
- 4560 kg
- Reason for recall
- Cross contamination: the excipient was found to be contaminated with theophylline.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
- Distribution pattern
- USA Nationwide and Worldwide
- Recall initiation date
- Nov 17, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 15, 2020